BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 23125001 · Received September 23, 2025

    Report

    Report Number
    3003707320-2025-00005
    Event Type
    Injury
    Date Received
    September 23, 2025
    Date of Event
    August 25, 2025
    Report Date
    September 23, 2025
    Manufacturer
    TIGER AESTHETICS MEDICAL LLC
    Product Code
    LMH
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT REPORTS SWELLING AFTER OFF-LABEL BELLAFILL INJECTIONS IN THE TEAR TROUGHS IN 2014. SHE STATES THAT SHE HAS ALSO HAD AN HYALURONIC ACID FILLER (BRAND UNKNOWN) IN THE SAME AREA IN (B)(6) 2024 AFTER WHICH LUMPS OCCURRED ALONG WITH THE SWELLING. PATIENT INDICATES ON (B)(6) 2025 THAT SHE IS SEEKING SURGICAL REMOVAL. IT IS UNKNOWN AT THIS TIME IF MEDICAL INTERVENTION IS REQUIRED TO RESOLVE THE ISSUE. PER THE BELLAFILL INSTRUCTIONS FOR USE: BELLAFILL IS INDICATED FOR THE CORRECTION OF NASOLABIAL FOLDS AND MODERATE TO SEVERE, ATROPHIC, DISTENSIBLE FACIAL ACNE SCARS ON THE CHEEK IN PATIENTS OVER THE AGE OF 21 YEARS. SEVERAL ATTEMPTS TO REACH THE PATIENT'S DOCTORS TO CONFIRM MEDICAL INTERVENTION REQUIRED WITHOUT RESPONSE AT THIS TIME. B3: DATE OF EVENT - 08/26/2025: DATE PATIENT INDICATED SHE WAS SEEKING REMOVAL OF PRODUCT. NO CONFIRMATION THAT SURGICAL INTERVENTION IS REQUIRED AT THIS TIME. D9: DEVICE NOT AVAILABLE FOR EVALUATION. BELLAFILL SYRINGES ARE SINGLE USE DEVICES THAT ARE TYPICALLY DISCARDED AFTER USE. PER BELLAFILL IFU: "THE SYRINGE AND ANY UNUSED MATERIAL SHOULD BE DISCARDED AFTER A SINGLE TREATMENT VISIT." D10: CONCOMITANT MEDICAL PRODUCS & THERAPY DATES: BRAND OF THE H.A. FILLER IS UNKNOWN. PATIENT PROVIDED ESTIMATED INJECTION DATE OF (B)(6) 2024, EXACT DATE IS UKNOWN. E1: THE INITIAL REPORTER WAS THE PATIENT. G3: DATE RECEIVED - REPORT INDICATING MEDICAL INTERVENTION IS REQUIRED RECEIVED FROM THE PATIENT ON (B)(6) 2025. BELLAFILL INJECTOR INFORMATION: DR. (B)(6), (B)(6), PHONE: (B)(6), (B)(6). TREATING PHYSICIAN INFORMAITON: DR. (B)(6), (B)(6), PHONE: (B)(6), (B)(6).

    Description of Event or Problem · 0

    PATIENT REPORTS SWELLING AFTER OFF-LABEL BELLAFILL INJECTIONS IN THE TEAR TROUGHS IN 2014. SHE STATES THAT SHE HAS ALSO HAD AN HYALURONIC ACID FILLER (BRAND UNKNOWN) IN THE SAME AREA IN (B)(6) 2024 AFTER WHICH LUMPS OCCURRED ALONG WITH THE SWELLING. PATIENT INDICATES ON (B)(6) 2025 THAT SHE IS SEEKING SURGICAL REMOVAL. IT IS UNKNOWN AT THIS TIME IF MEDICAL INTERVENTION IS REQUIRED TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219054 BELLAFILL DERMAL FILLER BELLAFILL DERMAL FILLER LMH TIGER AESTHETICS MEDICAL LLC AF0508 F141045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention HYALUONIC ACID DERMAL FILLER - BRAND UNKNOWN.